SwitzerlandSwitzerland

Auris presents positive safety data of inner ear tinnitus drug

28.01.2011

Basel – Swiss Auris Medical AG has reported positive safety data for its investigational drug AM-101 for the treatment for acute inner ear tinnitus in an ongoing phase I/II clinical trial. All doses from 30 to 810 µg/mL, which were administered by intratympanic injection, were well-tolerated by the 24 patients suffering from persisting moderate to severe tinnitus following acute noise trauma or sudden deafness. Incidence of adverse events (AEs) was low and similar in the verum and placebo arms. They were considered either unrelated or unlikely related to the treatment. No serious adverse events (SAEs) or AEs leading to withdrawal occurred during the study. AM-101 and its primary metabolite could be found in plasma samples obtained in the first hours following treatment in small amounts only (< 0.3 ng/mL), which confirmed the favourable safety profile of intra-tympanic injection. This minimally invasive procedure allows for a highly site specific treatment with low doses and only minimal systemic exposure. Additionally, Auris reported data pointing to efficacy of the NMDA receptor blocker. Both the subjective tinnitus loudness as measured by a 10 point visual analogue scale and the minimum masking level (MML) decreased, with the verum group showing greater improvements than the placebo group. Auris suggests that NMDA receptors in the cochlea play a major role in the occurrence of tinnitus following inner ear excitotoxicity.

SwitzerlandSwitzerland

21.02.2012

Basel/Berkeley – Europe enters into the age of personalised medicine. The European Commission has approved the melanoma drug Zelboraf. While the compound was developed by US-based Plexxikon Inc., owned by Daiichi Sankyo Group,...

SwitzerlandSwitzerland

26.01.2012

Basel – The rumours started just before Christmas. Roche wants Illumina. Just how dearly, has just become clear. The Swiss drugmaker made a $5.7b hostile bid for Illumina, the current market leader in Next-Generation sequencing....

SwitzerlandSwitzerland

23.01.2012

Basel – Good and bad news for Swiss drugmaker Novartis. First a look on the bright side: Signifor, for the treatment of Cushing's disease, is on its final stretch to approval. The Committee for Medicinal Products for Human Use...

SwitzerlandSwitzerland

19.12.2011

Basel - It is a further push for Roche's ambitions in medicine concerning the treatment of skin cancer: The European Committee for Medicinal Products for Human Use (CHMP) has recommended that the drug Zelboraf and its companion...

SwitzerlandSwitzerland

17.12.2011

Allschwil – Europe’s largest stand-alone biotech company Actelion Ltd. is receiving an injection of fresh capital. Under the guidance of the two biggest Swiss banks – UBS and Credit Suisse – the Swiss company will be issued a...

SwitzerlandSwitzerland

14.12.2011

Stans – Due to the current financial market conditions and the lack of significant progress with currently available options, Swiss drug developer Mondobiotech says it will be implementing restructuring measures. Together with...

SwitzerlandSwitzerland

14.12.2011

Geneva – There's is life in Swiss biotechnology beyond big pharma. Genentech has launched a First-in-Human study with anti-IL-17, an antibody made by the Swiss biotechnology company NovImmune. The fully human monoclonal antibody,...

SwitzerlandSwitzerland

22.11.2011

Basel – The FDA has withdrawn the accelerated approval for Roche's Avastin (bevacizumab) to treat metastasising breast cancer. The US regulatory authority had originally granted accelerated approval for Avastin's use in treating...

SwitzerlandSwitzerland

16.11.2011

Basel/Hervel – It may be the end of Novartis' lucky streak in osteoporosis. While the once a year osteoporosis injection Aclasta (a bisphosphonate) sells well, the Swiss pharma company had to break disastrous news from a...

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